Regulatory Affairs Manager
Regulatory Affairs Manager (Global Diagnostics)
Location: Remote within the EU
Employment Type: Full‑time
About the Role
Our client is seeking a Regulatory Affairs Manager to set global regulatory direction and lead strategy and execution for a portfolio of innovative diagnostic products. This role defines regulatory approaches across development, submission, and post‑market phases, partners with senior stakeholders, and ensures programs are aligned with evolving international requirements.
This is a senior, strategy‑owning position with visibility in governance forums and accountability for key regulatory outcomes across multiple regions.
What You Will Lead
Global Regulatory Strategy & Direction
- Establish end‑to‑end regulatory strategies for development, registration, and international expansion.
- Anticipate regulatory challenges and advise on implications for technical documentation, evidence plans, and launch sequencing.
Ownership of Major Deliverables
- Direct and approve complex global submissions and responses to authority questions.
- Oversee key elements of technical files (including IVDR) and ensure consistency across regions.
Senior Stakeholder Influence
- Represent Regulatory Affairs in program governance and cross‑functional leadership meetings.
- Provide clear regulatory recommendations to R&D, Clinical, Quality, and Commercial leaders.
Lifecycle & Portfolio Management
- Lead global lifecycle planning (changes, renewals, label expansions) and alignment across product families.
- Input to portfolio prioritization and pipeline readiness.
Regulatory Risk & Intelligence
- Drive risk assessments and mitigation strategies for complex/ambiguous pathways.
- Translate regulatory intelligence into actionable program adjustments.
Qualifications
- 7-10+ years in Regulatory Affairs within diagnostics, IVDs, or medical devices.
- Proven track record leading multi‑region regulatory strategies and major submissions.
- Strong knowledge of IVDR and international IVD frameworks (e.g., APAC, Middle East, Africa, India, non‑US North America).
- Demonstrated ability to influence senior stakeholders and drive decisions.
- Excellent communication and judgment in complex regulatory scenarios.
Preferred
- Experience in molecular diagnostics or other high‑complexity testing technologies.
- Leadership across simultaneous regional programs or launches.
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